Special Investigation of Kaletra in Pregnant Women

Human Immunodeficiency Virus Clinical Trial

Official title:

Special Investigation of Kaletra in Pregnant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076985
• Other study ID #: PMOS-JAP-00-002
• Status: Completed
• Phase: N/A
• First received: February 25, 2010
• Last updated: December 9, 2011
• Start date: December 2000
• Est. completion date: December 2010

Study information

• Verified date: December 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial Summary

This non-interventional, post-marketing observational study was conducted to obtain safety data from the use of lopinavir/ritonavir (Kaletra), in clinical practice, in pregnant women and their children in Japan.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All pregnant women who have received Kaletra for the treatment of HIV infection were eligible for this study

Exclusion Criteria:

• Contraindications according to the Package Insert:

• Patients with a history of hypersensitivity to any ingredient of Kaletra

• Patients who are receiving pimozide, cisapride, ergotamine tartrate, dihydroergotamine mesylate, ergometrine maleate, methylergometrine maleate, midazolam, triazolam, vardenafil hydrochloride hydrate, boriconazol

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Lopinavir/ritonavir (Kaletra)
Lopinavir/ritonavir (LPV/r) evaluated separately in patients who were naive to previous antiretroviral treatment and those who were not.

Locations

Country	Name	City	State
Japan	Site Reference ID/Investigator# 35862	Aichi
Japan	Site Reference ID/Investigator# 35863	Okayama
Japan	Site Reference ID/Investigator# 35864	Osaka
Japan	Site Reference ID/Investigator# 35865	Tokyo
Japan	Site Reference ID/Investigator# 5326	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Adverse Drug Reactions (ADRs)	The number of patients (mothers and infants) with adverse drug reactions, defined as adverse events for which the causal relationship with Kaletra was something other than "not related" by the investigator (i.e., "probable," "possible," or "unclear"). ADRs are reported by preferred term and inclusive of all those reported at any visit. Although a patient may experience a particular preferred term more than once, each patient was counted only once for each preferred term.	During pregnancy and for one year after birth	Yes